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Balmex Adult Care Rash by MOBERG PHARMA NORTH AMERICA LLC

Medically reviewed on December 13, 2017

Dosage form: cream
Ingredients: Zinc Oxide .113g in 1g
Labeler: MOBERG PHARMA NORTH AMERICA LLC
NDC Code: 16864-902

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients                                     Purpose
Zinc Oxide 11.3%Skin protectant

Uses
  • helps relieve and prevent rashes and irritation due to wetness from incontinence
  • protects chafed skin due to irritation and helps seal out wetness

Warnings

For external use only

When using this product
  • avoid contact with eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions
  • gently cleanse affected skin
  • pat dry with a clean, soft cloth or allow to air dry
  • apply generously to affected area as needed, especially after incontinence episodes
  • using a dry tissue to remove excess product from skin is most effective

Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

For more information please visit 
www.BalmexAdult.com

Distributed by Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
©2015 All Rights Reserved. Made in Canada.

PRINCIPAL DISPLAY PANEL

ActivGuard™

NEUTRALIZES IRRITANTS

Balmex®
ADULT CARE™
RASH CREAM

ZINC OXIDE 11.3%

Soothes & Protects Skin

From Irritation, Chafing & Rash

Dermatologist Tested
Works in One Use*
Odor-Free

NET WT 3 OZ (85 g)

Balmex® Adult Care™ Rash Cream is designed specifically to soothe and protect skin from the irritation, chafing, and rash caused by bladder leakage and proven to work in just one use.*

Powered by three proven ingredients:
• Exclusive ActivGuard™ technology neutralizes irritants
Vitamin E soothes and improves the healthy look of your skin
Zinc oxide helps seal out wetness and prevent future rashes

Distributed by Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2015 All Rights Reserved. Made in Canada.

82-3903-02

*Proven to work to reduce redness with first use.

For more information please visit www.BalmexAdult.com

Soothes & Protects Skin
From Irritation, Chang & Rash

Balmex®
ADULT CARE™
RASH CREAM

ActivGuard™

NEUTRALIZES IRRITANTS

ZINC OXIDE 11.3%

NET WT 12 OZ (340 g)

Balmex® Adult Care™ Rash Cream

When bladder leakage irritates your skin, it can seem impossible to get relief. Persistent moisture, painful friction, tough to reach and treat. Could there be a worse place to get a rash?

Now there's Balmex Adult Care Rash Cream—designed specifically to soothe and protect skin from the irritation, chafing, and rash caused by bladder leakage and proven to work in just one use.*

Powered by three proven ingredients:
Exclusive ActivGuard™ technology neutralizes irritants
Vitamin E soothes and improves the healthy look of your skin
Zinc oxide helps seal out wetness and prevent future rashes

For more information please visit: www.BalmexAdult.com

*Proven to work to reduce redness with first use.

Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2016 All Rights Reserved.
Made in Canada.
81-3909-02


BALMEX ADULT CARE RASH  
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-902
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide.113 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Mineral Oil 
Water 
Yellow Wax 
Microcrystalline Wax 
Sorbitan Sesquioleate 
Oenothera Biennis 
Olea Europaea Leaf 
Dimethicone 100 
Tocopherol 
Methylparaben 
Soybean Oil 
Propylparaben 
Dexpanthenol 
Sarcosine 
Benzoic Acid 
Potassium Aspartate 
Potassium Hydroxide 
Magnesium Aspartate Anhydrous 
Sodium Cocoyl Glycinate 
Propylene Glycol 
White Wax 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16864-902-011 TUBE in 1 CARTON
185 g in 1 TUBE
2NDC:16864-902-021 JAR in 1 CARTON
2340 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/27/2015
Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)

 
MOBERG PHARMA NORTH AMERICA LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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